This course introduces biopharmaceutical personnel to best practices, regulatory expectations and industry trends in the disciplines of facility cleaning, validation and environmental monitoring (EM). Instruction and hands-on laboratory work focus on essential industry guidance protocols that govern the effectiveness of cleaning procedures. Course materials cover facility cleaning methodologies, EM and validation procedures, and include extensive hands-on exercises using the PDI’s state-of-the-art cleanroom and lab facilities. Additionally, environmental monitoring theories and methods are implemented in order to validate cleaning processes in order to ensure that participants understand and are capable of implementing the actions needed to achieve industry standards.
Objectives
- This course introduces biopharmaceutical personnel to best practices, regulatory expectations and industry trends in the disciplines of facility cleaning, validation and environmental monitoring (EM).
- Instruction and hands-on laboratory work focus on essential industry guidance protocols that govern the effectiveness of cleaning procedures.
- Course materials cover facility cleaning methodologies, EM and validation procedures and include extensive hands-on exercises using PDI’s state-of-the art cGMP facility.
- Additionally, environmental monitoring theories and methods are implemented in order to validate cleaning processes in order to ensure that participants understand and are capable of implementing the actions needed to achieve industry standards.
Who should attend this course?
Individuals working in the Biomanufacturing industry including roles such as Quality Assurance, Regulatory, Quality Control, Validation, Operations, Microbiology, Facilities Maintenance, Engineering, and Plant Management disciplines.
Delivery
In-person lectures and hands on activities in a simulated GMP facility.
- Duration: 1 Day
- Time: 8:00am to 4:00pm
- Location: Kingston, RI
- Max Number of Participants: 15
Instructors
Content Outline
Lecture
- Brief Introduction to pharmaceuticals and biopharmaceuticals.
- Who develops the guidelines for cleaning and environmental monitoring for the food and drug industries?
- What type of facility will we be discussing?
- Where in the facility will we focus our attention?
- When is cleaning and environmental monitoring required?
- Why is cleaning and environmental monitoring required?
- How is cleaning performed and environmental monitoring used to validate the cleaning processes?
- Challenges
Lab Exercises
Cleanroom
- Collection of non-viable particles (Metone) pre-cleaning
- Collection of viable particles (touch plates/SAS) pre-cleaning
- Exercise in proper cleaning techniques
- Collection of non-viable particles (Metone) (post-cleaning)
- Collection of viable particles (touch plates/SAS) (post-cleaning) – Comparisons of collections will be sent by e-mail to students
Analytical Lab
- Evaluation of technique and effectiveness of cleaning
- Cleaning/disinfecting agent comparisons on select microbes
- Observation of results under microscope